clinical investigation for the foldax tria mitral valve- india

Conditions: Mitral Valve Disease; Mitral Regurgitation; Mitral Stenosis; Mitral Valve Insufficiency

Summary: the purpose of this study is to conduct a clinical investigation of the foldax tria mitral valve to collect evidence on the device's safety and performance.

the foldax tria mitral heart valve is indicated as a replacement for diseased, damaged, or malfunctioning native mitral heart valve via open heart surgery. the study is a single open are label non-randomized multi- center clinical trial. up to 10 sites in the country of india will enroll up to 70 patients. the first two patients at each site, will be considered roll-in patients accounting for training. up to 50 patients will be considered part of the treatment phase. these patients will follow the study schedule for 1 year after implantation.

Eligibility criteria:
inclusion criteria: * is 18 years or older * is a candidate for mitral valve replacement with cardiopulmonary bypass * is a candidate for mitral valve replacement due to severe mitral valve disease * no contraindication for anticoagulation treatment * willing and able to comply with protocol requirements exclusion criteria: * requires valve replacement other than mitral * prior mitral valve surgery for valve replacement or valve repair (this does not include percutaneous interventions i.e. mitraclip, chordal replacement) * required concomitant cardiovascular procedures except for cabg and/or cox-maze if approved by the screening committee * requires emergency surgery * requires other planned surgery within 12 months of valve replacement * active endocarditis or active myocarditis * exhibits left ventricular ejection fraction \</= 20% as validated by diagnostic procedure prior to planned valve surgery * acute preoperative neurological deficit defined as neurological deficit \< 3 months prior to enrollment * life expectancy of less than 12 months * enrolled in another investigational device or drug study (enrolled patients may not enroll in other studies) * myocardial infarction, or severe cardiac adverse event which has not returned to baseline for at least 30-days prior to enrollment * aortic aneurysm or other medical condition that creates a higher than usual risk of surgical complications * renal insufficiency as determined by creatinine (s-cr) level as \>/= 2.0 mg/dl or end stage renal disease requiring chronic dialysis at screening visit * results for the following blood tests are not within normal limits: d-dimer, basic metabolic panel liver enzymes, coagulation profile - platelets, aptt, inr, fibrinogen, c-reactive protein (hscrp) and esr, and troponin levels * hematological disorders, patients must not have a hematocrit of \<30%, hemoglobin \<10 g/dl, platelet count of \<100,000 cells/µl, or wbc \<4,000 cells/µl; coagulation profile must not be outside of normal limits * patients who are pregnant or expect to become pregnant in the 12 months following implantation, or are lactating * any other condition that, in the judgment of the investigator and screening committee, makes the patient a poor candidate for the procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, extensive travel away from the research center, covid-19 related concerns) * patients who have withdrawn after implantation may not re-enter * intraoperatively it is determined that the patient anatomy is not compatible with the device.